1. Field of the Invention
This invention relates to medical devices. More particularly, it relates to a device that monitors, measures and analyzes a variety of bodily functions.
2. Description of the Prior Art
Fetal heart tones and labor contractions are measured using sensors or instruments that are placed externally on the mother's body. This method is illustrated in prior art FIG. 1.
U.S. patent application Nos. 2009/0259133A1 and 2009/0192396A1 disclose the positioning of electrocardiogram (ECG) electrodes on the mother's abdomen to detect the fetal heart tone. Systems of this type rely on the detection of electrical impulses that originate from the heart muscles of the mother, the fetus, or both, myoelectric sensors capable of detecting muscle contractions, or Doppler ultrasound to detect heart movement.
There are a number of disadvantages to placing external monitors on the mother's body to monitor the fetal heart rate and intrauterine contractions as follows:
The fetal heart rate sensor performance can be compromised by:                Poor placement of sensors on mother's abdomen        Excessive amniotic fluid        Obese mother        Small or multiple babies        Movement of the baby out from under the sensor or sensors        Detection of mother's pulse instead of baby's pulse        The sensors are prone to falling off or moving, so the mother must remain still        
The contraction sensor performance is compromised because it:                Can only detect frequency and duration of contractions        Cannot provide direct measurement of intrauterine pressure intensity        Cannot provide comparative measurements of a series of contractions        
Fetal heart tones and labor contractions are also measured using sensors or instruments that are positioned in the mother's uterus and on the baby's head. This method is illustrated in FIG. 2.
There are a number of disadvantages to using an internal monitor installed within the mother's uterus or on the baby as follows:                The cervix must be dilated prior to placement of the monitors        Membranes must be ruptured to place monitor which commits mother/baby to delivery        Increased risk of infection to the baby        Increased risk of bruising of the baby's scalp        Possible uterine perforation/rupture        Potential for placental separation        
U.S. Pat. No. 6,434,418 discloses an instrumented catheter inserted into the bladder or rectum including a catheter balloon instrumented with pressure or myoelectric sensors to measure intrauterine pressure or detect contractions and a catheter tip instrumented with microphone, electrode or Doppler ultrasound probe to measure fetal heart rate. This method requires placement of electronic instrumentation within the body, it requires high-cost manufacturing of catheters having electronic instruments within them, it requires additional and non-standard procedures and personnel for placement of the catheter, and it requires that the entire catheter system be sterilized for re-use.
There are no known commercial products or technologies that non-invasively detect physiologic bladder changes during surgical procedures or provide direct measurement of acoustic fields and pressure variations within the bladder that could suggest bladder or ureteral injury.
Conventional blood pressure monitoring devices provide only pressure time histories of blood flow and do not measure to a sufficiently high frequency range acoustic or pressure variations that can be used to detect cardiovascular anomalies. Patent applications such as U.S. patent application No. 2010/00030095 disclose acoustic monitors and electronic stethoscopes to detect cardiovascular anomalies. However, the known devices do not provide direct measurement of acoustic fields and dynamic pressure variations of the blood within the blood vessels.
The known commercial products or technologies that enable direct measurement of acoustic fields and dynamic pressure variations due to respiration and blood flow within the lungs require the installation of measurement transducers within the lungs.
The prior art devices that enable direct measurement of acoustic fields and dynamic pressure variations due to digestion and blood flow within the stomach or upper digestive tract require the installation of measurement transducers within the stomach or upper digestive tract.
Commercial products or technologies that enable direct measurement of acoustic fields and dynamic pressure variations due to digestion and blood flow within the colon require the installation of measurement transducers within the colon.
What is needed, then, is a medical device that enables direct measurement of acoustic fields and dynamic pressure variations within such body parts without requiring that transducers by positioned within said body parts.
However, in view of the art considered as a whole at the time the present invention was made, it was not obvious to those of ordinary skill in the art that a medical device that enables direct measurement of acoustic fields and dynamic pressure variations within body parts without requiring transducers positioned within said body parts was needed nor was it obvious how such a device could be provided.